# K193155: Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Renal Solutions USA, Corp.
- Decided: Nov 25, 2020 after 377 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K843963 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901471: GC-1000 Through GC-3005 Acid Concentrate, Granite Chemical Co., Inc. (1990) Summary page 4.
- K993212: Dryasol Acid Concentrate Mix, Diasol, Inc. (1999) Summary page 4.
- K131202: Medicalyte (R) Bicarbonate Powder (36.83X), Medicalyte (R) Bicarbonate Powder (45X), Medicalyte (R) Bicarbonate Powder (35X, Dialysis Medical Solutions, LLC (2014) Summary page 4.

## Indications for use
For DA-100 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine. -or- For DA-200 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine. -or- For DA-300 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.

Source page: https://510kreport.com/device/K193155
Methodology: https://510kreport.com/methodology